How it works
An intelligence layer above your validated systems.
Altio sits above the systems you already run. It ingests documents and data across sources, builds the longitudinal record, and produces audit-ready outputs, replacing uncontrolled tooling with traceable, reproducible work.
It reads
- ICSRs and case narratives
- PSURs, DSURs, and literature
- Labels and health-authority queries
- Your own assessments and minutes
It produces
- Signal assessments
- Health-authority responses
- Safety committee packs
- Clinical study report sections
Each one drawn from the same institutional memory, extending to CTD and regulatory work, then medical affairs and evidence, as modules come online, with PBRER as a natural progression built with a design partner.
Connects to the stores you already run. Intake draws on public data such as FAERS alongside the documents you bring from your safety database, literature, and document management system, and signed deliverables flow downstream to Veeva Vault by API.
21 CFR Part 11
EU AI Act: not high-risk
ICH E2B(R3)
ISO 42001
Immutable audit trail
Human-in-the-loop
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